Bioequivalence and Bioavailability Forum

WHO lamenting about terminology? [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2020-12-07 14:35 (47 d 22:49 ago) – Posting: # 22124
Views: 564

Dear Helmut,

» Coming back to the WHO’s rant:

The calculation of the 90% confidence interval (CI) of the mean test/comparator ratio for the primary PK parameters should not be confused with the two one-sided t-tests employed to reject the null hypothesis of non-equivalence. The end result is the same, but these are not the same calculations.

» IMHO, they are just fed up reading “TOST” whilst the CI inclusion approach acc. to the GL was actually performed.

Totally correct to lament about that fact, I think. It should unequivocally described in the protocol or the SAP which calculations will be done . The CI approach will be the favorite I think. It is requested in all guidelines about BE studies, if I dont err.

Complete thread:

• WHO frequent deficiencies in protocols and reports Ohlbe 2020-12-04 12:04 [Regulatives / Guidelines] 
  • WHO frequent deficiencies in protocols and reports ElMaestro 2020-12-04 14:10
    • CI inclusion ≠ TOST Helmut 2020-12-04 20:30
      • CI inclusion ≠ TOST d_labes 2020-12-05 16:19
        • CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
          • CI inclusion ≠ TOST d_labes 2020-12-07 11:39
        • CI inclusion ≠ TOST Helmut 2020-12-06 22:09
          • CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
            • WHO lamenting about terminology? Helmut 2020-12-07 13:02
              • WHO lamenting about terminology? ElMaestro 2020-12-07 14:54
              • WHO lamenting about terminology?d_labes 2020-12-07 15:35
  • WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 19:00
    • "obtain balanced groups" vs randomisation ElMaestro 2020-12-23 08:12